Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- ADC Therapeutics S.A.
- Locations
- 1
- Primary Endpoint
- Number of Patients with Adverse Events
Study Overview
Brief Summary
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.
Detailed Description
The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must be ≥ 18 years of age at the time of consent.
- •Initiated or initiating commercially available loncastuximab tesirine treatment.
- •Written informed consent must be obtained prior to any registry activities.
Exclusion Criteria
- •Prior loncastuximab tesirine exposure in clinical trials.
Outcomes
Primary Outcomes
Number of Patients with Adverse Events
Time Frame: Up to 48 Months
Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions.
Time to Partial Response (PR)
Time Frame: Up to 48 Months
Time to Complete Response (CR)
Time Frame: Up to 48 Months
Progression-free Survival (PFS)
Time Frame: Up to 48 Months
Overall Survival (OS)
Time Frame: Up to 48 Months
Overall Response Rate (ORR)
Time Frame: Up to 48 Months
Duration of Response (DoR)
Time Frame: Up to 48 Months
Time to Disease Progression
Time Frame: Up to 48 Months
Secondary Outcomes
- Number of Hospitalizations(Up to 48 Months)
- Reasons for Surgeries(Up to 48 Months)
- Reasons for Outpatient Visits(Up to 48 Months)
- Number of Surgeries(Up to 48 Months)
- Reasons for Emergency Room Visits(Up to 48 Months)
- Number of Outpatient Visits(Up to 48 Months)
- Duration of Hospitalizations(Up to 48 Months)
- Number of Emergency Room Visits(Up to 48 Months)
- Reasons for Hospitalizations(Up to 48 Months)
- Type of Surgeries(Up to 48 Months)